French diabetes sufferers demanded a government crackdown on the pharmaceuticals industry as anger snowballed over a weight-control pill suspected of killing more than 500 people.

Representatives of French diabetes sufferers and consumers demanded a government crackdown on the pharmaceuticals industry as anger snowballed over a weight-control pill suspected of killing more than 500 people.

The French Diabetics Association teamed up with the national consumer federation to denounce an "opaque and obsolete" system where the financial firepower of drug firms dwarfed that of the public bodies that handle safety checks and sale authorisations.

The latest twist to France's biggest healthcare scandal in years followed news that the head of the national health safety agency was quitting because of a furore over the time it took France to ban the Mediator pill.

The pill

The pill made by the French company Servier was sold to around 5 million diabetics and people on slimming diets between 1976 and November 2009, when it was ordered withdrawn on safety grounds, several years after it was pulled in Spain and Italy.

It was pulled after official medical estimates that at least 500 people were killed due to exposure to the active ingredient in the pill, a molecule called benfluorex.

"I don't want to give you the whole history of Mediator but this medicine illustrates over 30 years the failings and dangers of the system governing drug introduction and monitoring," said Gerard Raymond, head of the French Diabetes Association (AFD).

"It's clear when you dig a bit deeper that this is not just an isolated case," he told journalists in a telephone conference.

Ready to seek clarity

In November, when the death toll estimate became public, Servier said the calculations did not reflect historical safety monitoring reports but that it was ready to help seek clarity.

Raymond's association and the country's principal consumer rights lobby, UFC-Que Choisir, said they had joined hundreds of others who are now demanding the opening of a criminal inquiry.

They called for full-scale reforms in France and at European level to boost standards of both pre-approval safety checks and follow-up monitoring as well as tougher control of drug purchase rebates under the social security system.

Conflict of interests

Gregory Caret of the UFC consumer lobby said it was vital to clean up a system riven with conflicts of interest and a massive mismatch between the power of a public health agency.

Its annual budget of 110 million Euros compares with the 2.4 billion Euros spent in 2004 by the industry on advertising, public relations gatherings and product promotion.

20,000 people visited doctors' offices

Drug companies in France deployed an army of 20,000 people to visit doctors' offices and promote products, twice as many as in Britain or Germany, he and colleagues told reporters.

And the public agencies in charge of drug safety checks often had to call on the services of people who were at the same time in the pay of the firms whose products were being vetted.

"It's fair to speak directly of conflicts of interest," Caret told.

A state health inspectorate is due to present a report to the government on the Mediator case on Saturday and President Nicolas Sarkozy has pledged to seek "the utmost transparency".

Doubts

Doubts about the efficacy of Mediator emerged as far back as the late 1990s, shortly after another diet drug made by the same company and based on a related, if not identical molecule, was banned on safety grounds, primarily heart valve trouble.

At least 500 deaths can be attributed to heart valve trouble caused by exposure to Mediator's benfluorex molecule between 1976 and November 2009, according to estimates from the French health insurance agency made public in November 2010.

Servier, which reported sales of 3.7 billion Euros in its latest financial year, is still run by its 88-year-old founder Jacques Servier, who was awarded France's national merit medal, the Legion d'Honneur, by Sarkozy less than a year before the Mediator drug was pulled. (Reuters Health/ January 2011)

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